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Wed, Mar 12
Thu, Mar 13
Fri, Mar 14
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Friday, March 14, 2025
8:00 AM – 9:00 AM
EST
Breakfast
8:00 AM – 9:00 AM
EST
Breakfast
Location: The Foyer
Supported by
8:00 AM – 12:00 PM
EST
Registration
8:00 AM – 12:00 PM
EST
Registration
Location: The Foyer
9:00 AM – 10:00 AM
EST
Harnessing Regulatory Intelligence for Global Compliance
9:00 AM – 10:00 AM
EST
Harnessing Regulatory Intelligence for Global Compliance
Location: Concourse A
Presenter:
Rupali Gupta, Associate Director, Regulatory Affairs
– BD
Presenter:
Samhitha Mohan, Sr.Staff Regulatory Affairs Specialist
– BD
Presenter:
Divya Raman, JD, MS, PMP
– Teleflex
Medical Devices (includes IVDs)
9:00 AM – 10:00 AM
EST
Regulatory Precedent and Intelligence from Labels; What Insights Can You Unlock From The Humble Label?
9:00 AM – 10:00 AM
EST
Regulatory Precedent and Intelligence from Labels; What Insights Can You Unlock From The Humble Label?
Location: Concourse B
Presenter:
Sam Kay, Mpharm
– Basil Systems
Pharmaceuticals (includes Biologics)
10:00 AM – 10:30 AM
EST
Coffee and Refreshments Break
10:00 AM – 10:30 AM
EST
Coffee and Refreshments Break
Location: The Foyer
Supported by
10:30 AM – 11:30 AM
EST
Global Regulatory Trends
10:30 AM – 11:30 AM
EST
Global Regulatory Trends
Location: Concourse A
Presenter:
Amra Racic
– Veeva Systems
Presenter:
Josh Silverstein, NA
– Philips
Medical Devices (includes IVDs)
10:30 AM – 11:30 AM
EST
Monitoring Health Authority Websites for Labeling Updates: A Case Study of Reference Safety Information Reporting
10:30 AM – 11:30 AM
EST
Monitoring Health Authority Websites for Labeling Updates: A Case Study of Reference Safety Information Reporting
Location: Concourse B
Presenter:
Patrice Lynds, MSHS, RAC
– Pfizer
Pharmaceuticals (includes Biologics)
11:40 AM – 12:40 PM
EST
Driving Product Success with Strategic Regulatory Intelligence
11:40 AM – 12:40 PM
EST
Driving Product Success with Strategic Regulatory Intelligence
Location: Concourse A
Presenter:
Rupali Gupta, Associate Director, Regulatory Affairs
– BD
Presenter:
Samhitha Mohan, Sr.Staff Regulatory Affairs Specialist
– BD
Medical Devices (includes IVDs)
11:40 AM – 12:40 PM
EST
Harnessing the Power of Collaboration: Explore a unique therapeutic area (TA)-focused Regulatory Intelligence (RI) model
11:40 AM – 12:40 PM
EST
Harnessing the Power of Collaboration: Explore a Unique Therapeutic Area (TA)-Focused Regulatory Intelligence (RI) Model
Location: Concourse B
Presenter:
Yvette Lawal, MBA
– Astrazeneca
Presenter:
Rebecca Lipsitz, PhD
– Astrazeneca
Presenter:
Meena N. Muthiah, MS, MPH, RAC
– AstraZeneca
Pharmaceuticals (includes Biologics)
12:40 PM – 1:40 PM
EST
Lunch Break
12:40 PM – 1:40 PM
EST
Lunch Break
Location: Flight Deck
Supported by
1:40 PM – 2:40 PM
EST
Mastering the Art of Communication: Enhancing Regulatory Policy & Intelligence Dissemination Within Drug and Device Organizations
1:40 PM – 2:40 PM
EST
Mastering the Art of Communication: Enhancing Regulatory Policy & Intelligence Dissemination Within Drug and Device Organizations
Location: Concourse A
Presenter:
Patrick J. Frey, MPP
– Neurocrine Biosciences
Presenter:
Stephanie S. Kelly, JD, MS
– Kyowa Kirin
Moderator:
James Lindsay Cobbs, RPh
– Apath Nexus
Combined Track
1:40 PM – 2:40 PM
EST
Regulatory Intelligence Strategy
1:40 PM – 2:40 PM
EST
Regulatory Intelligence Strategy
Location: Concourse B
Presenter:
Insun Ho, Ph.D
– Regulatory Affairs / Abbott
Presenter:
Elayne Kimmett, MBA, CQA, RAC
– Regeneron
Combined Track
2:40 PM – 3:00 PM
EST
Coffee and Refreshments Break
2:40 PM – 3:00 PM
EST
Coffee and Refreshments Break
Location: The Foyer
Supported by
3:00 PM – 4:00 PM
EST
Closing Plenary: Empowering Decision-Making: The Role of Regulatory Intelligence Professionals in Evaluating Vendors and Solutions
3:00 PM – 4:00 PM
EST
Closing Plenary: Empowering Decision-Making: The Role of Regulatory Intelligence Professionals in Evaluating Vendors and Solutions
Location: Concourse A
Panelist:
Sam Kay, Mpharm
– Basil Systems
Panelist:
Amin Osmani, MSc
– Cedience Inc.
Panelist:
Elizabeth Rosenkrands Lange, MS, MPH
– EMD Serono/ Merck KGaA, Darmstadt, Germany
Panelist:
Chris J. Whalley, BA
– Pfizer
Moderator:
James Lindsay Cobbs, RPh
– Apath Nexus
Combined Track